Drug recall
Andehist-DM NR Syrup, Antihistamine/Decongestant/Antitussive, Brompheniramine Maleate, 4mg, Pseudoephedrine…
FDA recall event 32233 · Class II · Able Laboratories, Inc.
Key facts
| Event ID | 32233 |
|---|---|
| Recall numbers | D-360-5, D-361-5, D-362-5, D-363-5 |
| Recalling firm | Able Laboratories, Inc. |
| Product type | Drugs |
| Products | Andehist-DM NR Syrup, Antihistamine/Decongestant/Antitussive, Brompheniramine Maleate, 4mg, Pseudoephedrine Hydrochloride, 45mg, Dextromethorphan Hydrobromide, 15mg, NDC 60258-444-16, 16 fl. oz…, Andehist NR Oral Drops, Antihistamine/Decongestant, Carbinoxamine Maleate,1mg, Pseudoephedrine Hydrochloride, 15mg, NDC 60258-435-30, 1 fl. oz, Mfg. by Liquisource, Inc (Able), New Brunswick, NJ 08901…, Andehist NR Syrup, Antihistamine/Decongestant, Brompheniramine Maleate 4mg, Pseudoephedrine Hydrochloride, 45mg. NDC 60258-434-16, 16 fl.oz, Mfg by: Liquisource, Inc (Able), New Brunswick, NJ 08901…, Bromhist-DM Drops, Brompheniramine Maleate, 1mg, Pseudoephedrine Hydrochloride, 15mg, Dextromethorphan Hydrobromide, 4mg, NDC 60258-447-30, 1 fl oz, Manufactured by LiquiSource, Inc (Able), New… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures. |
| Initiation date | May 25, 2005 |
| City | Cranbury |
| Country | United States |
| FEI number | 3004106764 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports